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STANDARD IMAGING, INC.

United States·US-MF-000009855

Last updated September 17, 2026

Information

Country: United States
Address: 3120, Deming Way, Middleton, United States
Website: www.standardimaging.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 608-824-7807
PRRC Contact: Ellen Lindquist
EUDAMED SRN: US-MF-000009855
FDA FEI Number: 1000115748
DUNS Number: —

Catalogue (80)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
MR Grid Phantom	91635	EUDAMED	Class I	Active
LUCY EA Phantom	91600	EUDAMED	Class I	Active
QA BeamChecker Pro	90503	EUDAMED	Class I	Active
TG-142 Phantom	91625	EUDAMED	Class I	Active
TruPose Head Adjuster	91710	EUDAMED	Class I	Active
Protective Lead Seed Pouch	90080	EUDAMED	Class I	Active
Exradin A30	92727	EUDAMED	Class I	Active
ISOCube Phantom	91640	EUDAMED	Class I	Active
MAX Elite Electrometer	90025	EUDAMED	Class I	Active
Standard Imaging Needle Cradle	90095	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Winston Lutz Cube Phantom	91345	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Stereotactic Dose Verification Phantom	91250	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A26 Ion Chamber	92746	EUDAMEDFDA UDI	Class I	Active
Standard Imaging MAX 4000 Plus Electrometer	90020	EUDAMEDFDA UDI	Class I	Active
Standard Imaging MIMI Phantom	91240	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Seed Slider	90090	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A10 Ion Chamber	92702	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin P11 Ion Chamber	92703	FDA UDI	Class I	Active
Standard Imaging Exradin A1SL Ion Chamber	92722	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin Magna 600	92600	EUDAMEDFDA UDI	Class I	Active
Standard Imaging HDR 1000 Plus	90008	FDA UDI	Class II	Active
Standard Imaging Exradin A20 Ion Chamber	92736	EUDAMEDFDA UDI	Class I	Active
Standard Imaging QA BeamChecker Plus	90501	EUDAMEDFDA UDI	Class I	Active
Standard Imaging QA StereoChecker	91349	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin W1 Scintillator	92739	EUDAMEDFDA UDI	Class I	Active
Standard Imaging CDX 2000B Electrometer	90001	FDA UDI	Class I	Active
Standard Imaging Exradin A6 Ion Chamber	92716	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A101 Ion Chamber	92680	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A11 Ion Chamber	92701	EUDAMEDFDA UDI	Class I	Active
Standard Imaging StructSure Software	91340	FDA UDI	Class I	Active
Standard Imaging Exradin A17 Ion Chamber	92675	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Reconstruction Jig Small	91285	EUDAMEDFDA UDI	Class I	Active
Standard Imaging SuperMAX Electrometer	90018	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin T2 Ion Chamber with Gas Flow	92743	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin D1H Diode Detector	92741	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A12 Ion Chamber	92700	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A8 Ion Chamber	92737	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A16 Ion Chamber	92726	EUDAMEDFDA UDI	Class I	Active
Standard Imaging LinacView Software	91330	EUDAMEDFDA UDI	Class II	Active
Standard Imaging Exradin D1V Diode Detector	92740	FDA UDI	Class I	Active
Standard Imaging Needle Loading Shield	90070	EUDAMEDFDA UDI	Class I	Active
Standard Imaging DoseView 1D	70800	FDA UDI	Class I	Active
Standard Imaging RAy Software	91336	FDA UDI	Class II	Active
Standard Imaging Lucy 3D QA Phantom	91210	FDA UDI	Class I	Active
Standard Imaging Exradin Magna 650 Ion Chamber	92650	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A12MR Ion Chamber	92904	EUDAMEDFDA UDI	Class I	Active
Standard Imaging MAX SD	90030	EUDAMEDFDA UDI	Class I	Active
Standard Imaging QA Pilot	91348	EUDAMEDFDA UDI	Class I	Active
Standard Imaging IMSure QA Software	v3	FDA UDI	Class II	Active
Standard Imaging Exradin A14SL Ion Chamber	92723	FDA UDI	Class I	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 28, 2003	Z-0952-03	—	terminated	Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.